Variable resistance sterilization process challenge device and method

ABSTRACT

A sterilization process challenge device has a sterilization indicator contained within a container; and a variable diffusion restriction into said container.

This application is a continuation of application Ser. No. 10/002,038filed Nov. 2, 2001, now U.S. Pat. No. 7,091,042, the contents of whichare hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to a process challenge device and methodfor determining the efficacy of a sterilization procedure.

BACKGROUND

Medical instruments are typically sterilized prior to use. Many methodsare employed, including steam sterilization, hydrogen peroxide, vaporphase sterilization, either with or without a gas plasma and ethyleneoxide (EtO). Each of these methods relates to a certain extent on thediffusion of fluid, primarily gaseous, sterilants into contact with theinstruments and devices to be sterilized.

Typically, such instruments and devices are packaged within containersor pouches having a semi-permeable barrier, which allows transmission ofthe sterilizing fluid but prevents admission of contaminating organisms.Packaging of the instruments in this fashion creates a diffusionrestriction somewhat inhibiting passage of the sterilizing fluid to thedevice or instrument. In addition, some devices and instruments havediffusion-restricted spaces therein; for example, endoscopes typicallyhave long narrow lumen. The sterilizing fluid must diffuse into thislong narrow lumen to effect sterilization therein. In addition todiffusion restrictions, the quantity of devices to be sterilized duringone process, and the amount of absorbent material in proximity theretoall affect how the sterilizing fluid travels to and contacts theinstruments to effect sterilization. A sufficient amount must remain incontact with the instrument for a sufficient period of time to achieve adesired level of sterilization.

To insure that proper sterilization has been achieved, it is typical toinclude some indicator of the sterilization process in proximity to thedevices or instruments to be sterilized during the process. Forinstance, a biological indictor having a predetermined quantity ofmicro-organisms can be placed within a sterilization chamber if thedevice is to be sterilized and, after the process is complete, it can becultured to determine whether any of the micro-organisms have survived.Biological indicators have evolved into designs in which a source ofgrowth media in a frangible container is located adjacent to a quantityof micro-organisms and after the sterilization procedure is completed,the frangible container is broken to release the growth media andculture any remaining living organisms. Typically, color indicationtechnology is included to show a color change in the presence of livingorganisms. Alternatively, an enzyme indicative of the organism viabilitymay be detected. Examples of such devices are shown in U.S. Pat. Nos.5,830,683 and 5,418,167, hereby incorporated by reference.

To more accurately replicate a challenge of diffusing a sterilant fluidinto contact with the device during an actual sterilization procedure,it has sometimes been the practice to place a biological indicatorinside of a challenge device having a diffusion restriction, such as along tortuous path. U.S. Pat. Nos. 5,895,627 and 5,872,004 illustrateexamples of such challenge devices, and are incorporated herein byreference.

SUMMARY OF THE INVENTION

A sterilization process challenge device according to the presentinvention comprises a sterilization indicator contained within acontainer and a variable diffusion restriction into the container.

The sterilization indicator can be a biological indicator or a chemicalindicator indicative of a chemical sterilant.

The variable diffusion restriction can comprise a diffusion path intothe container which can comprise an adjustable covering for the path toblock or unblock portion of the diffusion path. In one embodiment of theinvention, the container comprises a first member and second memberdisposed in telescoping relation with the openings disposed on the firstmember and the second member forming the adjustable covering.

The diffusion path can comprise a plurality of openings, which can bedifferent in size. At least one opening is preferably covered with aremovable covering. Rather than, or in addition to multiple openings,the diffusion path can comprise a slot, portions of which can be coveredor uncovered to vary the diffusion resistance.

The diffusion path can comprise a long narrow path, wherein thediffusion path can be adjusted by trimming the length of the path. Thediffusion path can comprise two or more materials wherein the materialshave different capabilities to retain sterilant. The diffusion path cancomprise a sterilant absorber such that the amount of sterilantdiffusing to the indicator can be adjusted by the type or the size ofthe absorber.

A method for assessing the sterilization efficacy of a sterilizationprocess according to the present invention comprises the steps of:placing a sterilization process challenge device in proximity to adevice to be sterilized during the sterilization process, thesterilization process challenge device comprising a container, asterilization indicator within the container, an opening into thecontainer and an adjustable diffusion restriction at the opening;assessing a feature of a load of one or more devices to be sterilized inthe sterilization process; adjusting the amount of diffusion restrictionprovided by the diffusion restriction based upon the feature of theload; and indicating the sterilization efficacy with the indicator.

The step of adjusting the amount of diffusion restriction can compriseadjusting an area of the opening into the container, such as by coveringor uncovering the opening into the container. The opening can comprise aplurality of apertures in a wall of the container.

The diffusion restriction can comprise a path into the container and thestep of adjusting the amount of diffusion restriction can compriseadjusting the length of the path.

The step of adjusting the diffusion restriction can comprise adjustingan amount of absorbent material placed adjacent the indicator.

The indicator can indicate whether a reference organism remains viableor whether a sufficient amount of a sterilizing gas was present duringthe sterilization process.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a challenge device according to the presentinvention;

FIG. 2 is a front elevation view of a second embodiment of a processchallenge device according to the present invention;

FIG. 3 is a front elevation view of a third embodiment of a processchallenge device according to the present invention;

FIG. 4 is a front elevation view of a fourth embodiment of a processchallenge device according to the present invention;

FIG. 5 is a top plan view of a fifth embodiment of a process challengedevice according to the present invention;

FIG. 6 is a top plan view of a sixth embodiment of a process challengedevice according to the present invention; and

FIG. 7 is a top plan view of a seventh embodiment of a process challengedevice according to the present invention.

DETAILED DESCRIPTION

FIG. 1 illustrates a process challenge device 10 according to thepresent invention. It comprises an enclosure 12 containing an indicator14 and diffusion restricted passage 16 leading into the enclosure 12.The enclosure 12 comprises a first open-ended body 18 and a secondopen-ended body 20 disposed in telescoping relation to one another. Thediffusion restricted passage 16 comprises a variety of apertures 22 inthe first body 18 which are selectively covered and uncovered by thesecond body 20 as the first and second body 18 and 20 are telescoped inrelation to one another. When all of the apertures 22 are uncovered, itis much easier for sterilizing fluid to diffuse into the enclosure 12and contact the indicator 14 than when only a few of the apertures 22are uncovered. Accordingly, the challenge device 10 provides an easy andsimple means for providing a process challenge, which can be adjusted inaccordance with the needs of a particular sterilization process.

FIG. 2 illustrates a similar process challenge device 24 comprising anenclosure 26 with an indicator 28 therein and it has a cover 30 at oneend, which can be rotated into various positions to vary the diffusionrestriction into the enclosure 26. An indicator mark 32 and scale 34 areprovided on the cover for indicating the amount of diffusion restrictionthat has been selected. The amount of diffusion restriction shouldcorrelate to the ease or difficulty in diffusing the sterilant intodevices to be sterilized, and the scale 34 may relate to a feature ofthe load relevant to such, as for instance the quantity of devices orthe length of the most challenging lumen in the load. Preferably,detents are provided between the cover 30 and enclosure 26, or somefriction is provided, to keep the cover in the proper position duringthe procedure. The diffusion restriction in this case can compriseapertures 36 selectively covered and uncovered by the cover 30 but cancomprise other restrictions of a variable nature.

FIG. 3 illustrates a third embodiment of a process challenge device 40according to the present invention. It comprises a container 42 having alid 44, and containing an indicator 46. A plurality of apertures 48provide a diffusion-restricted passage into the container 42. One ormore of the apertures are closed initially but may be opened by punchingout a disk 50. Preferably, the disk 50 is formed by shaping the surfaceof the container 42 in the shape of the aperture 48 creating a frangibleconnection between the disk 50 and the remaining material of container42.

The apertures disclosed in the first, second and third embodiments maybe the same in size, or may vary in size, with the user preferablypunching out or uncovering ever larger apertures to rapidly decrease thediffusion restriction. Especially with the first and second embodiments,the plurality of apertures could be replaced by a single elongated slot.The degree to which it is uncovered determines the diffusionrestriction. Such is illustrated in FIG. 4. It discloses a processchallenge device 52 similar to the challenge device 10 comprised offirst and second bodies 54 and 56 in telescoping relationship andcontaining therein an indicator 58. Rather than a plurality ofapertures, an elongated slot 59 through the first body 54 is fully orpartially uncovered through the telescoping relationship of the bodiesto determine the diffusion restriction.

FIG. 5 illustrates an alternative concept in which a process challengedevice 60 comprises a container 62 having an indicator 64 therein and atortuous path 66 leading to the indicator. Portions 68 of the container62 can be removed to shorten the tortuous path 66. For instance, if thecontainer is formed of mating polymer sheets with a channel formedtherein creating the tortuous path 66, portions of the sheets can be cutoff with scissors. Alternatively, the container 62 can be formed offilms with an at least partially rigid lumen placed therebetween to formthe path 66. Preferably, cut indication lines 70 are provided thereon toindicate particular locations to cut with a specified degree ofdiffusion restriction remaining.

Not only can the length of the tortuous path 66 be varied; it can beformed of material showing different levels of absorption. Preferably,that portion furthermost away from the indicator 64 would be formed ofthe most absorbent material and that portion closest to the indicatorformed of a low absorption or non-absorptive material. Such materialsinclude certain polymers known to absorb sterilants such as polyesters,polyurethanes, silicones, and nylons, which absorb hydrogen peroxide, ormore traditional absorbent materials such as cellulosic materials.Rather than form the path entirely of such absorbent materials, portionsof absorbent material can be located in select locations along the path.

FIG. 6 illustrates a further embodiment of a process challenge device 80comprising an elongated lumen 82 containing an indicator 84 at theclosed end 86 thereof. The length of absorbent material 88 is put intothe lumen 82 through an opposite open end thereof 90. Preferably, theabsorbent material 88 has markings 92 thereon to indicate places whereit can be cut or torn to reduce its length and, thus, its absorptivecapacity. The process challenge device 80 is disposed within abreathable pouch 94 to provide further diffusion restriction. Any of theembodiments herein can be enclosed in a further diffusion restriction toenhance the challenge they provide.

Each of the disclosed embodiments incorporates some form of indicator.This indicator is preferably a biological indicator such as described inthe background thereon but may also comprise an indicator for thepresence of a particular sterilant such as a chemical indicator for thepresence of hydrogen peroxide or the like. Such indicators are morefully described in U.S. Pat. Nos. 6,218,189 and 6,267,242 incorporatedherein by reference. Further, the indicator may be more active, such asa reactive chemical on a thermal couple to detect the presence of achemical sterilant as disclosed in pending U.S. patent application Ser.No. 09/741,594, filed Dec. 19, 2000, incorporated herein by reference.

FIG. 7 discloses a process challenge device 100 comprising a container102 having an indicator 104 therein. Elongated lumens 106 and 108 extendlaterally from the container 102. Each lumen 106 and 108 has markings110 thereon to indicate its length. Preferably, each lumen 106 and 108has an internal diameter of similar diameter to a particular devicebeing processed. For instance, an endoscope having a lumen of 1.5 metersand an internal diameter of 1 millimeter, each of the lumens 106 and 108would have an internal diameter of 1 mm and a length approximatelyone-half the length of the actual lumen, or 0.75 m to thus simulate thesterilant diffusing into the center of the device lumen.

In use, an operator would determine a certain characteristic of the loadsuch as the number of instruments, the number of wrapped instrumentcontainers, certain types of materials, which may be absorptive, or thelength of any difficult-to-sterilize lumens. This would then correlateto a particular setting on a process challenge device. For instance,using the process challenge device 10, the user may determine that only30 percent of the apertures 22 should be uncovered to provide a processchallenge indicative of the particular load to be sterilized. Thedevices and the process challenge device 10 are then sterilized in theusual manner. For instance, they may be placed into a steam sterilizerand processed, or into a hydrogen peroxide vapor sterilizer. One suchexample is the STERRAD® process from Advanced Sterilization Systems inwhich the devices are placed into a chamber which is evacuated and intowhich is introduced hydrogen peroxide vapor to sterilize the articles.At some point during the cycle, the hydrogen peroxide vapor is excitedinto plasma, which has the beneficial effect of leaving behind very fewresidual hydrogen peroxide molecules. After the procedure is completed,the process challenge device is removed and the indicator examined toassess the efficacy of the sterilization procedure.

It should be noted that the present invention is not limited to onlythose embodiments described herein. Any embodiment which retains thespirit of the present invention should be considered to be within itsscope. The invention is only limited by the scope of the followingclaims.

1. A sterilization process challenge device comprising: a sterilizationindicator contained within a container; a variable diffusion restrictioninto said container; and indicia associated with the variable diffusionrestriction indicative of an amount of diffusion restriction providedthereby.
 2. A sterilization process challenge device according to claim1 wherein the sterilization indicator is a biological indicator.
 3. Asterilization process challenge device according to claim 1 wherein thesterilization indicator is a chemical indicator indicative of a chemicalsterilant.
 4. A sterilization process challenge device according toclaim 1 wherein the variable diffusion restriction comprises a diffusionpath into said container.
 5. A sterilization process challenge deviceaccording to claim 4 wherein the diffusion path comprises an adjustablecovering for said path to block or unblock portion of said diffusionpath.
 6. A sterilization process challenge device according to claim 5wherein the container comprises a first member and second memberdisposed in telescoping relation with a plurality of openings disposedon the first member and the second member forming the adjustablecovering.
 7. A sterilization process challenge device according to claim4 wherein the diffusion path comprises a plurality of openings.
 8. Asterilization process challenge device according to claim 7 whereinopenings are different in size.
 9. A sterilization process challengedevice according to claim 7 wherein at least one opening is covered witha removable covering.
 10. A sterilization process challenge deviceaccording to claim 4 wherein the diffusion path comprises a slot.
 11. Asterilization process challenge device according to claim 4 wherein thediffusion path comprises a long narrow path, wherein the diffusion pathcan be adjusted by trimming the length of the path.
 12. A sterilizationprocess challenge device according to claim 11 wherein the diffusionpath comprises at least two materials wherein said materials havedifferent capabilities to retain sterilant.
 13. A sterilization processchallenge device according to claim 4 wherein the diffusion path furthercomprises a sterilant absorber such that the amount of sterilantdiffusing to the indicator can be adjusted by the type or the size ofthe absorber.
 14. A method for assessing the sterilization efficacy of asterilization process comprising the steps of: placing a sterilizationprocess challenge device in proximity to a device to be sterilizedduring the sterilization process, the sterilization process challengedevice comprising a container, a sterilization indicator within thecontainer, an opening into said container and an adjustable diffusionrestriction at said opening; assessing a feature of a load of one ormore devices to be sterilized in said sterilization process; adjusting,with assistance from indicia associated with the adjustable diffusionrestriction and being indicative of an amount of diffusion restrictionprovided by said adjustable diffusion restriction, the amount ofdiffusion restriction provided by said adjustable diffusion restrictionbased upon said feature of said load; and indicating the sterilizationefficacy with the indicator.
 15. A method according to claim 14 whereinthe step of adjusting the amount of diffusion restriction comprisesadjusting an area of the opening into the container.
 16. A methodaccording to claim 15 wherein the area of the opening is adjusted bycovering or uncovering the opening into the container.
 17. A methodaccording to claim 16 wherein the opening comprises a plurality ofapertures in a wall of the container.
 18. A method according to claim 14wherein the diffusion restriction comprises a path into the containerand the step of adjusting the amount of diffusion restriction comprisesadjusting the length of the path.
 19. A method according to claim 14wherein the step of adjusting the diffusion restriction comprisesadjusting an amount of absorbent material placed adjacent the indicator.20. A method according to claim 14 wherein the indicator indicateswhether a reference organism remains viable.
 21. A method according toclaim 14 wherein the indicator indicates whether a sufficient amount ofa sterilizing gas was present during the sterilization process.